UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037163 |
|---|---|
| Receipt number | R000042344 |
| Scientific Title | The effect of mastication on postprandial glucose metabolism |
| Date of disclosure of the study information | 2019/06/25 |
| Last modified on | 2021/06/28 15:30:46 |
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Basic information
Public title
The effect of mastication on postprandial glucose metabolism
Acronym
The effect of mastication on postprandial glucose metabolism
Scientific Title
The effect of mastication on postprandial glucose metabolism
Scientific Title:Acronym
The effect of mastication on postprandial glucose metabolism
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of the present study is to clarify the effect of physiological mastication (chewing) on postprandial glucose metabolism and gastric excretion.
Basic objectives2
Others
Basic objectives -Others
A participant will conduct 2 trials, mealtests with and without mastication. In the mealtest without mastication, participant will take a grinded testmeal, which has same nutrient composition as the trial with mastication, dissolved in water. The effect of mastication itself on postprandial glucose metabolism and gastric excretion independent of nutrient composition of the testmeal.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
plasma glucose levels (baseline, 15, 30, 45, 60, 90, and 120 min after taking a testmeal)
Key secondary outcomes
serum insulin and acetoaminophen levels, plasma GLP-1 level, postprandial energy expenditure
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
a bout of mealtest with mastication
Interventions/Control_2
a bout of mealtest without mastication
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Healthy adults with no present illness
Key exclusion criteria
a person taking oral hypoglycemic agents or insulin injection/a person with peptic ulcer/a person suffering from or has a history of aspirin-indiced asthma/oral diseases (doesnot matter whether having any prosthetic appliances or not)
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Hisayo |
| Middle name | |
| Last name | Yokoyama |
Organization
Osaka City University Graduate School of Medicine
Division name
Environmental Physiology for Exercise
Zip code
558-8585
Address
3-3-138, Sugimoto, Sumiyoshi-ku, Osaka City
TEL
06-6605-2947
yokoyama@sports.osaka-cu.ac.jp
Public contact
Name of contact person
| 1st name | Hisayo |
| Middle name | |
| Last name | Yokoyama |
Organization
Osaka City University Graduate School of Medicine
Division name
Environmental Physiology for Exercise
Zip code
558-8585
Address
3-3-138, Sugimoto, Sumiyoshi-ku, Osaka City
TEL
06-6605-2947
Homepage URL
yokoyama@sports.osaka-cu.ac.jp
Sponsor or person
Institute
Osaka City University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
JAPAN VASCULAR DISEASE RESEARCH FOUNDATION
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Osaka City University 0Certified Review Board for Medical Research
Address
1-2-7-601, Asahi-Machi, Abeno-ku, Osaka City
Tel
06-6645-3456
ethics@med.osaka-cu.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
大阪市立大学環境生理実験室
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 06 | Month | 25 | Day |
Related information
URL releasing protocol
none (paper only)
Publication of results
Published
Result
URL related to results and publications
none (paper only)
Number of participants that the trial has enrolled
8
Results
Eight healthy young individuals participated in the experiments for a two-meal test, in a crossover design. The postprandial blood glucose and insulin levels in the Chewing trial peaked significantly earlier than those in the Non-Chewing trial. The AUC of acetaminophen level in the Chewing trial was significantly greater than the Non-chewing trial The DIT was similar in the two trials.
Results date posted
| 2021 | Year | 06 | Month | 28 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
healthy young adults
Participant flow
participated in the experiments for a two-meal test by invitation, in a crossover design
Adverse events
none
Outcome measures
gastric excretion
postprandial blood glucose, insulin
diet-induced thermogenesis
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2019 | Year | 04 | Month | 25 | Day |
Date of IRB
| 2019 | Year | 04 | Month | 25 | Day |
Anticipated trial start date
| 2019 | Year | 07 | Month | 22 | Day |
Last follow-up date
| 2019 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 06 | Month | 25 | Day |
Last modified on
| 2021 | Year | 06 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042344
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| Registered date | File name |
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